Dentistry - Treatments & News Information for UK Dental Patients!

The Academy of General Dentistry supported the U.S. FDA July 28, 2009 ruling that dental amalgam is a safe and effective dental restorative material.

The FDA ruling involved reclassification of the mercury component of dental amalgam from a class I (low risk) to a class II (moderate risk) medical device placing it in the same class as gold and composite fillings.

This means the FDA can mandate special controls to help provide “reasonable assurance” of its safety and effectiveness.

The special controls include recommendations on performance testing, device composition, and labelling statements. Specific recommendations for product labelling include warnings against their use for the patients with mercury allergies or in poorly ventilated areas and a statement that reviews the benefits and risks of using dental amalgam.

Though, most people know dental amalgams as silver fillings, it is just not about silver, rather it is a mixture of mercury, tin and copper. Mercury, which makes up about 50% of the compound, is used to bind the metals together and to provide a strong, hard, durable filling.

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The Los Angles Times reported that the U.S. Food and Drug Administration released much awaited regulations on dental amalgam.

According to the recommendations of the agency, the product label should have the appropriate warning that dental professionals use adequate ventilation and that the amalgam not be used on people with mercury allergies.

The recommendation also mandates the product manufacturer to have the label which discusses the scientific evidence on the advantages and disadvantages of dental amalgam, including the risks of inhaled mercury vapour.

The recommendations come in the wake of much debated issue of whether amalgam fillings are good or injurious to health.   

The agency also found that the amount of mercury in people with amalgam fillings emerged to be quite below levels than the levels causing adverse health effects.

Even in adults and children ages 6 and above who have fifteen or more amalgam surfaces, mercury exposure due to dental amalgam fillings has been found to be far below the lowest levels associated with harm.

For more information, click the source.